Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A study to evaluate the safety and efficacy of multiple doses of etokimab in adults with chronic rhinosinusitis with nasal polyps.
This study is a randomized, placebo controlled, double-blind, multi-dose study to assess the efficacy of two different dose regimens of etokimab compared to placebo in adults with moderate-to-severe chronic sinusitis with nasal polyposis (CRSwNP).
During the screening period, all subjects will undergo evaluation for eligibility. A centralized reader will be used to confirm the diagnosis of CRSwNP as assessed by nasal endoscopy, computed tomography (CT) scan of sinuses, and symptom scoring to reduce the risk of interpretation variation.
Participants will also be provided mometasone furoate nasal spray (MFNS) for use during the trial and are required to undergo a minimum run-in period of 20 days prior to Day 1 with approximately 80% compliance.
Participants will be randomly assigned on Day 1 to one of the three treatment arms in a 1:1:1 ratio.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etokimab 300 mg + 150 mg Q4W | Experimental | Participants received a 300 mg loading dose of etokimab administered by subcutaneous injection at Week 0 then 150 mg etokimab by subcutaneous injection every 4 weeks (Q4W) up to Week 12 (Weeks 4, 8, and 12). Participants also used mometasone furoate nasal spray (MFNS) of 2 actuations (50 μg/actuation) in each nostril twice daily (BID). |
|
| Etokimab 300 mg + 150 mg Q8W | Experimental | Participants received a 300 mg loading dose of etokimab administered by subcutaneous injection at Week 0 then etokimab 150 mg by subcutaneous injection every 8 weeks (Q8W) up to Week 12 and placebo at Weeks 4 and 12. Participants also used MFNS of 2 actuations (50 μg/actuation) in each nostril BID. |
|
| Placebo | Placebo Comparator | Participants received placebo subcutaneous injection once every 4 weeks up to Week 12. Participants also used MFNS of 2 actuations (50 μg/actuation) in each nostril BID. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etokimab | Biological | Administered by subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Nasal Polyp Score (NPS) to Week 16 | Nasal polyps were evaluated by nasal endoscopy using centralized imaging data assessments scored by an independent reviewer. Each nostril was scored on a scale from 0 to 4, where a score of 0 means no polyps, and a score of 4 means the presence of polyps causing complete obstruction of the inferior nasal cavity. The bilateral NPS score is the sum of the right and left nostril scores, and hence the total NPS value is between 0 and 8 (worst). A negative change from Baseline indicates improvement. | Baseline and Week 16 |
| Change From Baseline in Sino-Nasal Outcome Test-22 (SNOT-22) Score at Week 16 | SNOT-22 is a 22-item outcome measure on a 5-category scale that assesses symptoms and social/emotional consequences of rhinosinusitis. Each item is scored from 0 (No problem at all) to 5 (Problem as bad as it can be), and the total score ranges from 0 to 110. Higher SNOT-22 scores are indicative of greater impact of rhinosinusitis on quality of life. A negative change from Baseline indicates improvement. | Baseline and Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Eosinophil Count | Baseline, Week 16, and Week 24 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| SM_ANB020-006@syneoshealth.com | AnaptysBio, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asthma & Allergy Institute | Little Rock | Arkansas | 72209 | United States | ||
| Alliance Research Institute |
Not provided
Not provided
Not provided
Not provided
Not provided
All participants entered a run-in period of between 20 and 31 days on mometasone furoate nasal spray (MFNS) of two actuations (50 μg/actuation) in each nostril twice daily (BID) prior to Day 1.
Eligible participants were randomly assigned on Day 1 to one of three treatment arms in a 1:1:1 ratio. Randomization was stratified by asthma comorbidity.
This study was conducted at 26 sites in the United States.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Etokimab 300 mg + 150 mg Q4W | Participants received a 300 mg loading dose of etokimab administered by subcutaneous injection at Week 0 then 150 mg etokimab by subcutaneous injection every 4 weeks (Q4W) up to Week 12 (Weeks 4, 8, and 12). Participants also used mometasone furoate nasal spray (MFNS) of 2 actuations (50 μg/actuation) in each nostril twice daily (BID). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 6, 2020 | Dec 14, 2021 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Biological | Administered by subcutaneous injection |
|
| Mometasone Furoate Nasal Spray | Drug | Mometasone Furoate Nasal Spray (MFNS) was used from 4 weeks prior to Day 1 (Run-in period) through the end of the study. Participants used 2 actuations (50 μg/actuation) in each nostril BID, total daily dose of 400 μg. Participants intolerant to BID intranasal corticosteroids (INCS) could use the lower dose regimen of 1 actuation in each nostril BID, total daily dose of 200 μg. |
|
| Canoga Park |
| California |
| 91304 |
| United States |
| DaVinci Research | Roseville | California | 95661 | United States |
| Sacramento Ear Nose and Throat Surgical and Medical Group Inc. - SacENT | Sacramento | California | 95815 | United States |
| Allergy & Asthma Medical Group and Research Center | San Diego | California | 92123 | United States |
| Colorado Allergy Asthma Centers | Denver | Colorado | 80230 | United States |
| Intermed Medical Research Center | Miami | Florida | 33175 | United States |
| Advanced Research Institute, Inc. | New Port Richey | Florida | 34653 | United States |
| Clinical Research Consultants of Atlanta | Suwanee | Georgia | 30024 | United States |
| Treasure Valley Medical Research | Boise | Idaho | 83706 | United States |
| Chicago ENT | Chicago | Illinois | 60657 | United States |
| Advanced ENT and Allergy | Louisville | Kentucky | 40213 | United States |
| Chesapeake Clinical Research Inc. | Baltimore | Maryland | 21236 | United States |
| ENT and Allergy Associates ENTA LLP | New York | New York | 10016 | United States |
| University of North Carolina Hospitals | Chapel Hill | North Carolina | 27599 | United States |
| Charlotte Eye Ear Nose and Throat Associates | Matthews | North Carolina | 28105 | United States |
| Ohio Sinus Institute | Dublin | Ohio | 43016 | United States |
| Allergy Asthma Clinical Research Center | Oklahoma City | Oklahoma | 73120 | United States |
| Allergy Asthma and Immunology Center P.C. | Tulsa | Oklahoma | 74136 | United States |
| Central States Research, LLC | Tulsa | Oklahoma | 74136 | United States |
| National Allergy and Asthma Research | North Charleston | South Carolina | 29420 | United States |
| Fort Worth ENT Berkson Medical | Fort Worth | Texas | 76109 | United States |
| Ear Nose and Throat Associates of Texas | McKinney | Texas | 75070 | United States |
| Intermountain Ear Nose Throat Specialist | Draper | Utah | 84020 | United States |
| Chrysalis Clinical Research | St. George | Utah | 84790 | United States |
| Eastern Virginia Medical School EVMS Medical Group | Norfolk | Virginia | 23507 | United States |
| Bellingham Asthma Allergy Immunology Clinic | Bellingham | Washington | 98225 | United States |
| Allergy, Asthma Sinus Center, SC | Greenfield | Wisconsin | 53228 | United States |
| FG001 |
| Etokimab 300 mg + 150 mg Q8W |
Participants received a 300 mg loading dose of etokimab administered by subcutaneous injection at Week 0 then etokimab 150 mg by subcutaneous injection every 8 weeks (Q8W) up to Week 12 and placebo at Weeks 4 and 12. Participants also used MFNS of 2 actuations (50 μg/actuation) in each nostril BID. |
| FG002 | Placebo | Participants received placebo subcutaneous injection once every 4 weeks up to Week 12. Participants also used MFNS of 2 actuations (50 μg/actuation) in each nostril BID. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Etokimab 300 mg + 150 mg Q4W | Participants received a 300 mg loading dose of etokimab administered by subcutaneous injection at Week 0 then 150 mg etokimab by subcutaneous injection Q4W up to Week 12 (Weeks 4, 8, and 12). Participants also used MFNS of 2 actuations (50 μg/actuation) in each nostril BID. |
| BG001 | Etokimab 300 mg + 150 mg Q8W | Participants received a 300 mg loading dose of etokimab administered by subcutaneous injection at Week 0 then etokimab 150 mg by subcutaneous injection Q8W up to Week 12 and placebo at Weeks 4 and 12. Participants also used MFNS of 2 actuations (50 μg/actuation) in each nostril BID. |
| BG002 | Placebo | Participants received placebo subcutaneous injection once every 4 weeks up to Week 12. Participants also used MFNS of 2 actuations (50 μg/actuation) in each nostril BID. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Age, Customized | Count of Participants | Participants |
| |||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Nasal Polyp Score (NPS) | Nasal endoscopies were performed using centralized imaging data assessments and scored by an independent reviewer. Nasal polyps were scored from 0 (no polyps) to 4 (polyps causing complete obstruction of the inferior nasal cavity). The bilateral NPS score is the sum of the right and left nostril scores, hence the total NPS ranges from 0 to 8 (worst). | The full analysis set included all randomized participants who received at least one dose of etokimab or placebo, and had a Baseline and at least one post-Baseline NPS and/or SNOT-22 score up to Week 16. | Mean | Standard Deviation | score on a scale |
| ||||||||
| Sino-Nasal Outcome Test (SNOT-22) Score | SNOT-22 is a 22-item outcome measure on a 5-category scale that assesses symptoms and social/emotional consequences of rhinosinusitis. Each item is scored from 0 (No problem at all) to 5 (Problem as bad as it can be), and the total score ranges from 0 to 110. Higher SNOT-22 scores are indicative of greater impact of rhinosinusitis on quality of life. | The full analysis set included all randomized participants who received at least one dose of etokimab or placebo, and had a Baseline and at least one post-Baseline NPS and/or SNOT-22 score up to Week 16. | Mean | Standard Deviation | score on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Nasal Polyp Score (NPS) to Week 16 | Nasal polyps were evaluated by nasal endoscopy using centralized imaging data assessments scored by an independent reviewer. Each nostril was scored on a scale from 0 to 4, where a score of 0 means no polyps, and a score of 4 means the presence of polyps causing complete obstruction of the inferior nasal cavity. The bilateral NPS score is the sum of the right and left nostril scores, and hence the total NPS value is between 0 and 8 (worst). A negative change from Baseline indicates improvement. | Full analysis set with available data | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Week 16 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Sino-Nasal Outcome Test-22 (SNOT-22) Score at Week 16 | SNOT-22 is a 22-item outcome measure on a 5-category scale that assesses symptoms and social/emotional consequences of rhinosinusitis. Each item is scored from 0 (No problem at all) to 5 (Problem as bad as it can be), and the total score ranges from 0 to 110. Higher SNOT-22 scores are indicative of greater impact of rhinosinusitis on quality of life. A negative change from Baseline indicates improvement. | Full analysis set participants with available data | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Week 16 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Eosinophil Count | Safety analysis set with available data at each time point | Posted | Mean | Standard Deviation | 10^9 cells/L | Baseline, Week 16, and Week 24 |
|
From first dose of study medication on Day 1 until Week 16, or up to 28 days after the last dose of study medication for participants who discontinued treatment earlier than Week 16.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Etokimab 300 mg + 150 mg Q4W | Participants received a 300 mg loading dose of etokimab administered by subcutaneous injection at Week 0 then 150 mg etokimab by subcutaneous injection Q4W up to Week 12 (Weeks 4, 8, and 12). Participants also used MFNS of 2 actuations (50 μg/actuation) in each nostril BID. | 0 | 35 | 2 | 35 | 8 | 35 |
| EG001 | Etokimab 300 mg + 150 mg Q8W | Participants received a 300 mg loading dose of etokimab administered by subcutaneous injection at Week 0 then etokimab 150 mg by subcutaneous injection Q8W up to Week 12 and placebo at Weeks 4 and 12. Participants also used MFNS of 2 actuations (50 μg/actuation) in each nostril BID. | 0 | 35 | 0 | 35 | 8 | 35 |
| EG002 | Placebo | Participants received placebo subcutaneous injection once every 4 weeks up to Week 12. Participants also used MFNS of 2 actuations (50 μg/actuation) in each nostril BID. | 0 | 35 | 0 | 35 | 6 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinusitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (21.1) | Systematic Assessment |
|
Results from a center cannot be submitted for publication before results of multicenter study are published unless it is 18 months since study completion. Then, Investigator can publish if manuscript is submitted to Sponsor 90 days prior to submission. Sponsor may require the Investigator to remove specifically identified Confidential Information (other than Trial Data) and/or to delay the proposed publication for an additional 60 days to enable Sponsor to seek patent protection for Inventions.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Leader | AnaptysBio, Inc. | 858-362-6295 | info@anaptysbio.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 7, 2020 | Dec 14, 2021 | SAP_001.pdf |
Not provided
|
|
|
|
|
|
|
| Superiority |
Statistical significance for the co-primary efficacy endpoints would be declared if both p-values for the tests of the individual hypotheses were < 0.05. |
| A general linear mixed effects model with repeated measures (MMRM) was used including the change from Baseline in NPS as dependent variable; treatment group, stratification factor, time (Weeks 4, 8, 12, and 16), treatment by stratification factor, and treatment by time interaction as fixed effect factors; Baseline NPS as covariate; and subject as random effect. | General linear MMRM | 0.2024 | Testing was conducted in a hierarchical manner such that the comparison of etokimab Q4W versus placebo was conducted first. If the results of this comparison were statistically significant, the etokimab Q8W treatment arm would be compared to placebo. | LS Mean Difference | -0.41 | Standard Error of the Mean | 0.316 | 2-Sided | 95 | -1.03 | 0.22 | Superiority | Statistical significance for the co-primary efficacy endpoints was to be declared if both p-values for the tests of the individual hypotheses were < 0.05. |
Participants received placebo subcutaneous injection once every 4 weeks up to Week 12. Participants also used MFNS of 2 actuations (50 μg/actuation) in each nostril BID. |
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|